drugset / Trial / NCT04193527

A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients

NCT04193527 ↗

Phase 3 Completed 172 enrolled GE Healthcare PPD Development, LP · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease \[PD\] \[SDD\], multiple system atrophy \[MSA\] \[SDD\] or or progressive supranuclear palsy \[PSP\] \[SDD\]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.

Timeline

Start
2020-06-28
Primary completion
2021-12-20
Completion
2021-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject ioflupane 123I Unknown 111 mbq Intravenous
Subject ioflupane 123I Unknown 185 mbq Intravenous